This invention relates to a process bag container utilized to mix reagent ingredients, to sense the characteristics of the resultant mixture and to dispense the resultant mixture.
Presently, a wide variety of reagents including cell culture supplements, buffers, media or the like are utilized in the biotechnology industry in producing and purifying biological products such as protein. The reagents are generally produced from two compositions at least one of which is a liquid. The biological products produced with these reagents are required to be produced under conditions to avoid product contamination.
Presently, process bag containers are formed from a flexible polymeric material and are adapted with inlets which permit introduction of reagents into the container and an outlet to dispense a mixture of the reagents from the container. The bag generally is provided with a mixing device such as an impeller that is connectable to a power source such as a magnetically coupled motor so that it can be rotated thereby to promote mixing of the reagents within the container. Other devices may use top mounted stirrers or impellers on a shaft that extends into the bag through a journal. In use, the flexible container is placed within a rigid housing that supports the container so that reagent mixing followed by dispensing can be effected.
Since reagents utilized in the production of biological products must be accurately controlled or monitored regarding their composition such as pH, conductivity, oxygen content, or temperature, it is desirable to provide a means for measuring such composition and environmental values during reagent mixture production.
Accordingly, it would be desirable to provide a process bag container which permits mixing of reagents therein. In addition, it would be desirable to provide such a container which permits monitoring the composition of a reagent within the container in which the reagent is produced. Furthermore, it would be desirable to provide such a container which does not have its wall compromised during production and monitoring of the reagent within the container. Additionally, it would be of benefit to provide a probe that does not require the rigid housing to be modified such as with holes to access protruding sensors and route cable connections.
Lastly, most sensors are long and extend inward horizontally to a tank. This often requires a large amount of space on the interior and exterior of the tank to accommodate the sensor(s). Additionally, there is need for alignment of the bag with the rigid container so that the sensor ports are in register with each other and accessible to the user. These protruding elements are also subject to bumping, misalignment, calibration loss and damage. A new design is desired that minimizes the risk to the sensor(s) and providing a more compact assembly so as to minimize the length to which a sensor protrudes past the bag outline.